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Bioequivalence Study of Budesonide/Formoterol Inhalation Powder in Healthy Participants

NCT07804303 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-09-04

No results posted yet for this study

Summary

The goal of this study is to learn if a new formulation of Budesonide/Formoterol Inhalation Powder (160μg/4.5μg), manufactured by Shanghai New Huanghe Pharmaceutical Co., Ltd., works the same as the already approved reference product, Symbicort® Turbuhaler® (160μg/4.5μg), in the body. It will also learn about the safety of the new formulation.

The main questions it aims to answer are:

* How quickly and how much of the study drug gets into the blood after inhalation, compared with the reference product?
* What medical problems do participants have when taking the study drug?

Researchers will compare the new formulation to the reference product (the already approved treatment) to see if they are bioequivalent.

Participants will:

* Be randomly assigned to receive either the new formulation or the reference product in the first period, then switch to the other in the second period
* Take a single dose of 2 inhalations in each period, with a 4-day washout period between doses
* Have 22 blood samples collected over 36 hours after each dose to measure drug levels in the blood
* Visit the clinic for checkups, including vital signs, physical examinations, and laboratory tests
* Be monitored for any side effects throughout the study

Conditions

  • Asthma
  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Test)

160 μg/4.5 μg, administered as 2 inhalations, manufactured by Shanghai New Huanghe Pharmaceutical Co., Ltd.

DRUG

Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Reference)

160 μg/4.5 μg, administered as 2 inhalations, manufactured by AstraZeneca AB.

Sponsors & Collaborators

  • Shanghai Xin Huanghe Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-13
Primary Completion
2024-01-22
Completion
2024-01-24

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07804303 on ClinicalTrials.gov